A Clinical Evaluation of a Steroid-Coated Sinus Stent When Used Following Functional Endoscopic Sinus Surgery in Patients With Chronic Sinusitis

Phase 3

Completed

Interventions: Device: Sinus Stent with drug coating
Device: Non Coated Sinus Stent

Brief Summary: The purpose of this study is to assess the safety and efficacy of the Propel mometasone furoate implant when used following Functional Endoscopic Sinus Surgery (FESS) in patients with Chronic Sinusitis (CS).

Detailed Description: The purpose of this study is to assess the safety and efficacy of the Propel mometasone furoate implant when used following Functional Endoscopic Sinus Surgery (FESS) in patients with Chronic Sinusitis (CS). The Propel implant is designed to provide a mechanical spacing function within the sinus anatomy to separate mucosal tissues, provide stabilization of the middle turbinate, and thereby prevent tissue adhesions from forming. The implant is coated with a small amount of mometasone furoate (a corticosteroid) in order to help minimize post surgical inflammation within the supported tissues.

The study utilizes an intra-patient control design to assess the safety and efficacy of the drug-coated implant compared to the non-drug coated implant that is identical in appearance.

Recruitment & Eligibility

Inclusion Criteria

Patient has bilateral chronic sinusitis confirmed by CT scan and defined as inflammation of the mucosa of the nose and paranasal sinuses of at least 8 consecutive weeks' duration.
Patient is indicated for and has consented to FESS.
FESS successfully completed without significant complication that in the opinion of the physician would confound study results and the patient's anatomy remains amenable to Sinus Stent placement.

CT Imaging Inclusion Criteria:

CS diagnosis confirmed and documented by CT Scan within 6 months of the procedure.
Patient has minimum total CT score (Lund-Mackay method) of 6. • Patient has bilateral ethmoid sinus disease confirmed by CT.

Exclusion Criteria

Arm && Interventions

Group	Intervention	Description
Drug Coated	Sinus Stent with drug coating	Sinus stent coated with steroid
Non coated	Non Coated Sinus Stent	Sinus stent without drug coating

Primary Outcome Measures

Name	Time	Method
Percentage of Sinuses Requiring Post-operative Intervention	30-days	Post-operative interventions include either need for surgical adhesion lysis or the need for oral steroids prescription, as determined from video-endoscopies reviewed by a panel of independent blinded sinus surgeons.
Percentage of Patients With Clinically Significant Increase in Intra-ocular Pressure	90 days	clinically significant IOP elevation is a change from baseline of \>10 mm Hg on sinus side with drug-coated implant but not on side with control implant

Secondary Outcome Measures

Name	Time	Method
Percentage of Sinuses That Developed Frank Polyposis	30 days	Frank polyposis means polyps grade 2 or 3, which was determined from video-endoscopies reviewed by a panel of independent blinded sinus surgeons.

Locations (11): Colorado ENT & Allergy
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Colorado Springs, Colorado, United States
Charlotte Eye, ENT Associates
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Charlotte, North Carolina, United States
Eastern Virgina Medical School
🇺🇸
Norfolk, Virginia, United States
Northwestern University
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Chicago, Illinois, United States
University of Texas Medical School
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Houston, Texas, United States
Central California ENT
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Fresno, California, United States
Northshore University Health System
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Evanston, Illinois, United States
University of Texas SW Medical School
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Dallas, Texas, United States
Intermountain ENT
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Salt Lake City, Utah, United States
Advanced ENT & Allergy
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Louisville, Kentucky, United States
Austin ENT Clinics
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Austin, Texas, United States